Pain, Postoperative
Conditions
Keywords
Pain, Postoperative, Ofirmev, Acetaminophen, Analgesics, Non-Narcotic, Arthroscopy
Brief summary
The purpose of this randomized, placebo controlled, single blind study is to determine if postoperative pain levels, as measured by a verbal numeric pain rating scale (VNRS), are reduced with the administration of IV acetaminophen when compared to a control group. Particular focus will be on the postoperative opioid consumption. In addition, we will ascertain if the total time the participant is in the PACU differs in those who receive the IV acetaminophen versus those who do not.
Detailed description
This is a randomized, placebo controlled, single blind study of intravenous (IV) acetaminophen in a postoperative arthroscopy patient population. Although use of this medication as a non-narcotic analgesia has been validated in other patient populations such as post operative pelvic and abdominal surgeries, it has not been demonstrated in those who have recently undergone knee arthroscopy with or without chondroplasty. In this study all participants will be injected with a standard of care intra-articular dose of ropivacaine HCl, .2% (Naropin) prior to transfer to the Post Anesthesia Care Unit (PACU). Each will be randomized 1:1 to receive IV acetaminophen in 100ml of 0.9% NS (treatment group) or a 100 ml 0.9 % NS placebo (control). The PACU nursing staff will periodically ascertain the participants' pain scores on a 0-10 scale. All other pain medication or related treatment will be recorded. Statistical analysis will be done to determine if there is a difference in pain scores between the treatment versus control group. Further evaluation will examine if opioid consumption and total time in PACU differs between groups.
Interventions
Participants randomized to intravenous acetaminophen (Ofirmev) will receive an infusion of Ofirmev in 100 ml of 0.9 NS according to manufacturer's recommendations related to subject's weight.
DRUGPlacebo (0.9% Normal Saline infusion)
Infusion of 100 ml of 0.9% NS
Sponsors
University of Central Florida
AdventHealth
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Is scheduled for knee arthroscopy with or without chondroplasty. * Scheduled arthroscopy procedure will not include ligament repairs or ligament reconstructions and/or bone cutting or fixation procedures. * Has not received any acetaminophen (IV, PR, PO) within at least 8 hours of the initiation of surgery. * Is willing and able to sign an informed consent.
Exclusion criteria
* Is undergoing arthroscopy for ligament repairs/reconstructions and bone cutting or fixation procedures * Has self-reported and/or documented previous hypersensitivity to acetaminophen. * Has self-reported and/or documented history of hepatic disease or impairment. * Pre-operative calculated creatinine clearance (CrCL) less than 40 ml/min. * Has a medical history of alcohol abuse and/or currently drinks more than 3 alcoholic beverages per day. * Has a medical history of substance dependence (i.e. prescription analgesics or illegal drugs such as cocaine, heroin, etc…). May be self-reported or maybe per the judgment of the physician PI/Sub-I.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Levels | up to 8 hours | To determine if postoperative pain levels, as measured by a Verbal Numerical Rating Scale (VNRS), are reduced with the administration of IV acetaminophen when compared to a control group. In the VNRS, the user has the option to verbally rate their scale from 0 to 10. Zero indicates the absence of pain, while 10 represents the most intense pain possible. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Opioid Consumption | up to 8 hours | To learn if opioid consumption is reduced when IV acetaminophen is provided immediately post-operatively. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Total Time in Post Anesthesia Care Unit (PACU) (or Recovery Room) | up to 8.6 hours | To ascertain if the total time the participant remains in the PACU (from admission to discharge) differs between those who received IV acetaminophen versus those who do not receive IV acetaminophen. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intravenous Acetaminophen Infusion of Intravenous acetaminophen (Ofirmev)
Intravenous Acetaminophen: Participants randomized to intravenous acetaminophen (Ofirmev) will receive an infusion of Ofirmev in 100 ml of 0.9 NS according to manufacturer's recommendations related to subject's weight. | 65 |
| Placebo (0.9% Normal Saline Infusion) Infusion of 100 ml of 0.9 NS Normal Saline
Placebo (0.9% Normal Saline infusion): Infusion of 100 ml of 0.9% NS | 54 |
| Total | 119 |
Baseline characteristics
| Characteristic | Intravenous Acetaminophen | Placebo (0.9% Normal Saline Infusion) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 25 Participants | 20 Participants | 45 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants | 34 Participants | 74 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 34 Participants | 32 Participants | 66 Participants |
| Sex: Female, Male Male | 31 Participants | 22 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 65 | 0 / 54 |
| other Total, other adverse events | 0 / 65 | 0 / 54 |
| serious Total, serious adverse events | 0 / 65 | 0 / 54 |
Outcome results
Primary
Postoperative Pain Levels
To determine if postoperative pain levels, as measured by a Verbal Numerical Rating Scale (VNRS), are reduced with the administration of IV acetaminophen when compared to a control group. In the VNRS, the user has the option to verbally rate their scale from 0 to 10. Zero indicates the absence of pain, while 10 represents the most intense pain possible.
Time frame: up to 8 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Acetaminophen | Postoperative Pain Levels | 1.3160 score on a scale | Standard Deviation 1.3351 |
| Placebo (0.9% Normal Saline Infusion) | Postoperative Pain Levels | 2.1362 score on a scale | Standard Deviation 1.59323 |
Secondary
Postoperative Opioid Consumption
To learn if opioid consumption is reduced when IV acetaminophen is provided immediately post-operatively.
Time frame: up to 8 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intravenous Acetaminophen | Postoperative Opioid Consumption | 3 mg |
| Placebo (0.9% Normal Saline Infusion) | Postoperative Opioid Consumption | 2 mg |
Other Pre-specified
Total Time in Post Anesthesia Care Unit (PACU) (or Recovery Room)
To ascertain if the total time the participant remains in the PACU (from admission to discharge) differs between those who received IV acetaminophen versus those who do not receive IV acetaminophen.
Time frame: up to 8.6 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intravenous Acetaminophen | Total Time in Post Anesthesia Care Unit (PACU) (or Recovery Room) | 3.30 hours |
| Placebo (0.9% Normal Saline Infusion) | Total Time in Post Anesthesia Care Unit (PACU) (or Recovery Room) | 3.40 hours |